Report: FDA promise of 1 million coronavirus tests this week unattainable

Tuesday, March 3, 2020

Source: MassDevice

The FDA grossly overestimated the number of coronavirus diagnostic tests that would be available this week as well as U.S. laboratories’ capacity to process them, according to a report in the New York Times.

FDA commissioner Stephen Hahn told reporters on Monday that the agency’s decision allowing private labs to make their own tests would broaden their capacity to perform those tests, the Times report said.

The agency on Feb. 4 authorized the emergency use of a coronavirus test at the request of the Centers for Disease Control and Prevention (CDC). That test is manufactured by Integrated DNA Technologies, but increased production does not affect laboratories’ capacity to conduct the testing, the Times reported. New guidance the FDA issued on Feb. 29 allows any CLIA-certified, high-complexity laboratory to go through the process to become certified to test.

Scott Becker, CEO of the Association of Public Health Laboratories, said on Saturday that his organization expects public health laboratories will have the capacity to conduct 10,000 tests a day by the end of this week.  On Monday, Becker dialed that back, saying that labs can conduct about 100 tests per day, but that only half of them have the capacity to do so, the Times reported.

An apparent manufacturing defect in the initial tests rolled out by the CDC has caused a delay in upping the supply of tests, according to a report by Politico. The U.S. Department of Health and Human Services is  investigating the problem.

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